(129 days)
CUTIVA™ Topical Skin Adhesive (RM1700) is intended for topical application only, to hold closed easily approximated skin edges of wounds from surgical incisions, including punctures from minimally invasive surgery, and simple, thoroughly cleansed trauma-induced lacerations. CUTIVA™ Topical Skin Adhesive (RM1700) should be used in conjunction with, but not in place of, deep dermal stitches.
The CUTIVA™ PLUS Skin Closure System (RM1739) is intended for topical application only to hold closed easily approximated skin edges of wounds from surgical incisions, including punctures from minimally invasive surgery, and simple, thoroughly cleansed, trauma-induced lacerations. CUTIVA™ PLUS Skin Closure System (RM1739) should be used in conjunction with, but not in place of, deep dermal stitches. Additionally, the adjunct wound closure device component maintains temporary skin edge alignment along the length of the wound during the application of the liquid adhesive.
CUTIVA™ Topical Skin Adhesive (RM1700) and the CUTIVA™ PLUS Skin Closure System (RM1739) are skin closure devices that are comprised of a 2-octyl cyanoacrylate liquid adhesive formulation. The liquid adhesive is supplied sterile within a single use dispensing applicator, which is used to deliver the adhesive to the skin. The CUTIVA™ PLUS Skin Closure System (RM1739) also incorporates a self-adhering mesh component that is applied to the wound prior to the application of the liquid adhesive to align the skin edges. The liquid adhesive is then applied to the mesh with the adhesive applicator to complete the device application.
Once applied, the liquid adhesive polymerizes to form a thin film with strong bonding and tensile properties. CUTIVA™ Topical Skin Adhesive (RM1700) and the CUTIVA™ PLUS Skin Closure System (RM1739) provide a physical barrier to microbial penetration as long as the adhesive film remains intact. In vitro studies have been performed to demonstrate the microbial barrier properties of CUTIVA™ Topical Skin Adhesive (RM1700) and the CUTIVA™ PLUS Skin Closure System (RM1739) for 72 hours after device application. No clinical studies have been performed and no clinical benefit associated with the in vitro microbial barrier performance of the device has been demonstrated.
This FDA 510(k) clearance letter pertains to a topical skin adhesive, not an AI/ML medical device. Therefore, much of the requested information (e.g., sample size for test set, number of experts, adjudication method, MRMC study, standalone performance, training set size, ground truth for training set) is not applicable or cannot be extracted from this document, as these concepts are specific to the validation of AI/ML algorithms, not traditional medical devices like skin adhesives.
However, I can provide the available information regarding acceptance criteria and the study that supports the device, focusing on what is relevant for a non-AI/ML medical device.
Device Name: CUTIVA™ Topical Skin Adhesive (RM1700); CUTIVA™ PLUS Skin Closure System (RM1739)
1. Table of Acceptance Criteria and Reported Device Performance
Given this is a 510(k) for a traditional medical device (topical skin adhesive) and not an AI/ML algorithm, the "acceptance criteria" discussed are typically related to biocompatibility, physical properties, and safety, assessed against recognized standards. The document primarily focuses on biocompatibility testing as a "performance data" highlight for the labeling change.
| Acceptance Criteria Category | Specific Criteria (Implied/Directly Stated) | Reported Device Performance |
|---|---|---|
| Microbial Barrier Properties | In vitro demonstration of microbial barrier properties for 72 hours. | In vitro studies demonstrated microbial barrier properties for 72 hours after device application. (Note: No clinical benefit associated with this in vitro performance has been demonstrated.) |
| Biocompatibility (Systemic Toxicity) | No evidence of systemic toxicity from the test article following subcutaneous implantation in rats (per ISO 10993-11:2017). | The "Subacute Systemic Toxicity (Implant Method) in Rats (ISO 10993-11:2017)" study demonstrated: |
- No evidence of systemic toxicity.
- Microscopically, the test article caused a minimal or no reaction.
- Worst-case exposure conditions were created by implanting the maximum dose. |
| Biocompatibility (Reaction) | Minimal or no local reaction at the implantation site. | Microscopically, the test article was classified as causing a minimal or no reaction. |
| Substantial Equivalence | The device is substantially equivalent to a legally marketed predicate device. | Both CUTIVA™ Topical Skin Adhesive (RM1700) and CUTIVA™ PLUS Skin Closure System (RM1739) were found substantially equivalent to their respective predicate devices (K234114) since they are the same devices with only packaging insert modifications. |
2. Sample Size for the Test Set and Data Provenance
- Sample Size for Test Set: Not explicitly stated in terms of human subjects or a "test set" for performance evaluation in the context of an AI/ML algorithm. For the biocompatibility study, it involved "test animals" (rats), but the exact number is not provided.
- Data Provenance: The biocompatibility study was performed in accordance with ISO 10993-11:2017 standards, implying a controlled laboratory study. The country of origin is not specified, but the study method adheres to international standards. It is a prospective animal study for biocompatibility.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
- Not applicable in the context of this device. The ground truth for biocompatibility studies is typically derived from established biological assays and pathological analysis by trained professionals (e.g., toxicologists, histopathologists), not from "experts" establishing ground truth in an image-reading or diagnostic context.
4. Adjudication Method for the Test Set
- Not applicable for this type of device and study. Adjudication methods like 2+1 or 3+1 are used for human reader consensus in diagnostic studies, which is not relevant here.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- Not applicable. This is a traditional medical device (skin adhesive), not an AI/ML algorithm requiring an MRMC study to assess human reader improvement.
6. Standalone Performance Study (Algorithm Only)
- Not applicable. This is a traditional medical device, not an algorithm.
7. Type of Ground Truth Used
- For Microbial Barrier Properties: In vitro laboratory testing results, comparing microbial penetration with and without the adhesive.
- For Biocompatibility: Histological examination and physiological observations on test animals (rats) to determine systemic toxicity and local tissue reaction, based on the criteria of ISO 10993-11:2017.
8. Sample Size for the Training Set
- Not applicable. This is a physical device, not an AI/ML algorithm that requires a training set.
9. How the Ground Truth for the Training Set Was Established
- Not applicable. As there is no AI/ML algorithm, there is no training set and thus no ground truth to establish for it.
§ 878.4010 Tissue adhesive.
(a)
Tissue adhesive for the topical approximation of skin —(1)Identification. A tissue adhesive for the topical approximation of skin is a device intended for topical closure of surgical incisions, including laparoscopic incisions, and simple traumatic lacerations that have easily approximated skin edges. Tissue adhesives for the topical approximation of skin may be used in conjunction with, but not in place of, deep dermal stitches.(2)
Classification. Class II (special controls). The special control for this device is FDA's “Class II Special Controls Guidance Document: “Tissue Adhesive for the Topical Approximation of Skin.” See § 878.1(e) of this chapter for the availability of this guidance document.(b)
Tissue adhesive for non-topical use —(1)Identification. A tissue adhesive for non-topical use, including adhesives intended for use in the embolization of brain arteriovenous malformation or for use in ophthalmic surgery, is a device used for adhesion of internal tissues and vessels.(2)
Classification. Class III (premarket approval). As of May 28, 1976, an approval under section 515 of the act is required before this device may be commercially distributed. See § 878.3 of this chapter.